PAN-PROMISE to Detect Post-ERCP Pancreatitis Symptoms

Post-ERCP Acute Pancreatitis Clinical Trial

— PAN-PROMISE  

Official title:

A Prospective Cohort Study Evaluating PAN-PROMISE, a Patient-Reported Outcome Measure, To Detect and Risk-Stratify Post-ERCP Pancreatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05310409
• Other study ID #: PAN-PROMISE
• Status: Completed
• Start date: September 15, 2020
• Est. completion date: January 1, 2023

Study information

• Verified date: July 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to use a validated patient-reported outcome measure to evaluate how many patients have symptoms of pancreatitis after ERCP and how it correlates with their quality of life and productivity.

Description:

This project will measure the impact of a recently validated patient-reported outcome measure for acute pancreatitis, PAN-PROMISE, to detect post-ERCP pancreatitis symptoms and capture its morbidity. The study will compare the change of PAN-PROMISE before and after ERCP to the current standard diagnostic criteria for post-ERCP pancreatitis, the Cotton Consensus Criteria. The main limitations of the Cotton-Consensus Criteria are that it fails to capture outpatient or ambulatory morbidity, uses length of stay to define the severity of pancreatitis without accounting for local or systemic complications for pancreatitis, and it has limited sensitivity in patients with chronic symptoms such as patients with chronic pancreatitis or pancreatic adenocarcinoma. These limitations have impeded the evaluation of potential therapies to prevent post-ERCP pancreatitis. PAN-PROMISE will help capture and quantitate the morbidity related to post-ERCP pancreatitis and thus will enhance our ability to optimize outcomes following ERCP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: January 1, 2023
• Est. primary completion date: August 1, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients undergoing ERCP

2. Age >= 18 years old

3. Intact major papilla

Exclusion Criteria:

1. Unwillingness or inability to consent for the study

2. Age < 18 years

3. Standard contraindications to ERCP

4. Intrauterine pregnancy

5. Prior hepaticojejunostomy in a patient undergoing ERCP for a bile duct indication

6. Prior pancreaticojejunostomy in a patient undergoing ERCP for a pancreatic duct indication

7. Low probability of completing the follow-up

8. Acute pancreatitis (by the Revised Atlanta criteria) in the seven days prior to ERCP.

9. Patients who do not answer at least 80% of the questions on the baseline and 48-hour follow-up survey.

10. Patients who could not be contacted via a telephone call to assess for post-ERCP complications at 48-72 hours.

11. Patients who speak a language other than English, Spanish, Bulgarian, Mandarin, English, French, German, Greek, Hungarian, Italian, Korean, Polish, Portuguese, Romanian, Russian, Turkish, Ukrainian, or Hindi (as the PAN-PROMISE has only been translated and validated in these languages.

Related Conditions & MeSH terms

• Pancreatitis
• Post-ERCP Acute Pancreatitis

Locations

Country	Name	City	State
United States	University of Pennsylvania Health System	Philadelphia	Pennsylvania
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

References & Publications (4)

Artifon EL, Chu A, Freeman M, Sakai P, Usmani A, Kumar A. A comparison of the consensus and clinical definitions of pancreatitis with a proposal to redefine post-endoscopic retrograde cholangiopancreatography pancreatitis. Pancreas. 2010 May;39(4):530-5. doi: 10.1097/MPA.0b013e3181c306c0. — View Citation

de-Madaria E, Sanchez-Marin C, Carrillo I, Vege SS, Chooklin S, Bilyak A, Mejuto R, Mauriz V, Hegyi P, Marta K, Kamal A, Lauret-Brana E, Barbu ST, Nunes V, Ruiz-Rebollo ML, Garcia-Rayado G, Lozada-Hernandez EE, Pereira J, Negoi I, Espina S, Hollenbach M, Litvin A, Bolado-Concejo F, Vargas RD, Pascual-Moreno I, Singh VK, Mira JJ. Design and validation of a patient-reported outcome measure scale in acute pancreatitis: the PAN-PROMISE study. Gut. 2021 Jan;70(1):139-147. doi: 10.1136/gutjnl-2020-320729. Epub 2020 Apr 3. — View Citation

Masci E, Toti G, Mariani A, Curioni S, Lomazzi A, Dinelli M, Minoli G, Crosta C, Comin U, Fertitta A, Prada A, Passoni GR, Testoni PA. Complications of diagnostic and therapeutic ERCP: a prospective multicenter study. Am J Gastroenterol. 2001 Feb;96(2):417-23. doi: 10.1111/j.1572-0241.2001.03594.x. — View Citation

Thiruvengadam NR, Forde KA, Ma GK, Ahmad N, Chandrasekhara V, Ginsberg GG, Ho IK, Jaffe D, Panganamamula KV, Kochman ML. Rectal Indomethacin Reduces Pancreatitis in High- and Low-Risk Patients Undergoing Endoscopic Retrograde Cholangiopancreatography. Gastroenterology. 2016 Aug;151(2):288-297.e4. doi: 10.1053/j.gastro.2016.04.048. Epub 2016 May 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of Life Assessment	will capture changes in Quality of Life using the SF-12 instrument.	30 days
Primary	Post-ERCP Pancreatitis	will define post-ERCP pancreatitis using the Cotton Consensus Criteria with a 3 physician adjudication committee.	7 days after ERCP
Primary	PROM-PEP	will capture the work abseentism and loss of productivity using the Work-Productivity and Activity Impairment Questionnaire and will express in in 2021 US Dollars.	30 days
Secondary	Direct Health Care Costs	will capture the direct healthcare costs using the Medicare Reimbursement data and express it in 2021 US Dollars.	30 days